Hello soulguide,
You have asked a very interesting question. The manufacturer appears
to be Boie-Takeda Chemicals, Inc. located in the Philippines. I found
the following document related to that:
http://www.lawphil.net/judjuris/juri1988/may1988/gr_82568_1988.html
Republic of the Philippines
SUPREME COURT
Manila
FIRST DIVISION
G.R. No. 82568 May 31, 1988
HON. ALFREDO R.A. BENGZON, in his capacity as Secretary of Health,
HON. CATALINA C. SANCHEZ, in her capacity as the Director of Food and
Drugs of the NATIONAL DRUG COMMITTEE of the Department of Health,
petitioners,
vs.
COURT OF APPEALS and BOIE-TAKEDA CHEMICALS, INC., respondents.
The Solicitor General for petitioners.
Herrera, Laurel, De los Reyes, Roxas and Teehankee Law Offices for
respondents.
GRIÑO-AQUINO, J.:
The petitioner filed on April 5, 1988 a petition for review on
certiorari of the writ of preliminary injunction that was issued on
March 3, 1988 by the Court of Appeals (Tenth Division) in CA-G.R. No.
13859 entitled, "BOIE-TAKEDA CHEMICALS INC., Petitioner versus
DEPARTMENT OF HEALTH, HON. ALFREDO R.A. BENGZON, in his capacity as
Secretary of Health, et al., Respondents."
enjoining respondents and all persons acting under them from enforcing
and/or giving effect to Regulation No. 1 dated 1 April 1987 (Annex
"B," Petition), Regulation No. 1-A dated 10 April 1987 (Annex "C") and
to the order dated 1 February 1988 (Annex "Q") and from conducting
further proceedings, which shall issue upon petitioners bond for
P250,000.00 executed to the respondents to the effect that petitioner
will pay such damages as they may sustain and prove by reason of the
writ if it should finally be decided that petitioner is not entitled
thereto.
The petitioners pray that the said writ of preliminary injunction be
annulled and set aside and that its enforcement be temporarily
restrained during the pendency of this case.
Respondent Boie-Takeda Chemicals, Inc. (hereafter referred to as
"BOIE-TAKEDA" for brevity) filed a motion to dismiss the petition, and
an opposition to the application for a writ of preliminary injunction.
Treating the motion to dismiss and opposition as the respondents'
comment or answer to the petition, We decided to immediately resolve
the merits of the petition.
Under Republic Act No. 3720 of June 22,1963, the petitioner Secretary
of Health is charged with the duty and vested with authority "to
insure safe and good quality supply of drugs and to regulate the
production, sale, and traffic for the same to protect the health of
the people." (Sec. 2) To implement this policy, the Government shall:
(a) Establish standards and quality measures for food, drug, and
cosmetic.
(b) Adopt measures to insure pure and safe supply of food, drug, and
cosmetic in the country.
As amended by Executive Order No. 175 dated May 22, 1987, the statute
now empowers the Department of Health to:
(a) Establish standards and quality measures for foods, drugs and
devices and cosmetics.
(b) Adopt measures to ensure pure and safe supply of foods and
cosmetics, and pure, safe, efficacious and good quality drugs and
devices in the country.
(c) Adopt measures to ensure the rational use of drugs and devices,
such as, but not limited to, banning, recalling or withdrawing from
the market drugs and devices which are not registered unsafe,
inefficacious or of doubtful therapeutic value, the adoption of an
official National Drug Formulary, and the use of generic names in the
labelling of drugs.
(d) Strengthen the Bureau of Food and Drugs.
Respondent Boie-Takeda is a Philippine corporation which is engaged in
the manufacture, distribution, and sale of drugs, among them "Danzen"
a tablet which contains serra-peptase, an OPE (oral anti-inflammatory
proteolytic enzymes) which it has been licensed to manufacture and
sell in the Philippines since 1970. This drug is also being sold in
other countries such as Japan and in the Federal Republic of Germany.
However, it is not sold in the United States.
Based on a decision dated May 30,1985 of the U.S. Food and Drug (FDA)
Commissioner, and affirmed by the U.S. Court of Appeals on April 1,
1986, which determined that "oral anti-inflammatory proteolytic
enzymes (OPE) which are labelled for use in controlling edema and
inflammation associated with surgical, obstetrical, or dental
procedures or accidental trauma to any part of the body or infections
or allergic manifestations, have not been shown to be effective for
such uses," the petitioner Catalina C. Sanchez, as Director of the
Bureau of Food and Drugs, with the approval of petitioner Alfredo R.A.
Bengzon, as Secretary of Health, "in the interest of consumer
protection," issued on April 1, 1987 BFAD Regulation No. 1 s. 1987,
ordering that:
l. The registration of all pharmaceutical preparations containing
anti-inflammatory proteolytic enzymes, as listed in ANNEXES "A,"
"A-1," "A-2" and "B," "B-l" and "B-2" hereof are herby ordered
recalled, which means that these drugs should no longer be marketed in
the Philippines.
2. For the orderly phasing out of stocks which have been distributed
to outlets prior to the issuance of this Order, all stocks should have
been recalled and withdrawn by the manufacturer and distributor by
October 30, 1987. (Annex "A" of Petition.)
After a week, as an addendum to BFAD Regulation No. 1, the petitioners
issued BFAD Regulation No. 1-A s. 1987 dated April 10, 1987, including
in the list of banned pharmaceutical preparations Boie-Takeda's Danzen
tablet, 5 mg. with serratio-peptidase 10,000 U. (Annex B, Petition.)
Boie-Takeda filed with the Secretary of Health a request for
reconsideration of BFAD Regulation No. 1-A on the grounds that:
l. Serrapeptase was never registered in the United States and as a
consequence, data related to this enzyme was not part of the review
made by the US FDA.
2. Since there has been no hearing called in connection with oral
proteolytic enzymes by the Bureau of Food and Drugs, the Philippine
regulatory authority, there has been no opportunity to submit data
relating to serra-peptase.
3. Voluminous data on Serrapeptase has, on 20 April 1987, been
submitted to the BFAD, including what might be considered carefully
designed double-blind studies of serrapeptase against placebo, studies
demonstrating intestinal absorption of serrapeptase by measureable
quantities of the enzymia in lymph, arterial blood and venous blood,
by radio-immunoassay techniques.
4. In addition, a considerable number of additional clinical studies
showing clinical effectiveness of serrapeptase in various conditions,
done in West Germany, France, Italy and other countries, are available
and can be submitted to the BFAD.
5. Serrapeptase is registered and approved drug in some 20 countries,
including the ASEAN nations, and most recently in the Federal Republic
of Germany.
6. There is evidence that serrapeptase has demonstrable effectiveness
not only as an anti-inflammatory drug, which was the indication for
which oral proteolytic enzymes were registered in the United States,
but also as a mucolytic and as an agent that enhances penetration of
antibiotics and other chemotherapeutic agents into the sites of
pathology. Documentation regarding these uses has been submitted to
the BFAD and additional material can be supplied if necessary.
7. Additional studies are still being conducted in various parts of
the world, the results of which, we anticipate, will further augment
the evidence demonstrating the effectivity and uses of serrapeptase."
(Annex Code. Petition.)
After a 15-minute hearing before the members of the Technical Advisory
Committee on Registration of Products (TACORP), Director Sanchez of
the Bureau of Food and Drugs denied Boie-Takeda's request for
reconsideration (Annex E).
Boie-Takeda appealed to the Secretary of Health (Annex F) who referred
the appeal to the National Drug Committee (NDC) which granted the
appellant a 20-minute hearing where it submitted voluminous
documentation proving the efficacy and safety of its product (Annex
M), but to no avail. On February 1, 1988 Secretary Bengzon informed
Boie-Takeda that the National Drug Committee confirmed the recall and
cancellation of registration of "Danzen" tablets and directed the
company "to discontinue marketing the said product effective as of
receipt of this notice." (Annex N).
Alleging that the cancellation of the registration of its product was
done without due process of law, Boie-Takeda filed in the Court of
Appeals a petition for certiorari and prohibition with preliminary
injunction (CA-G.R. SP No. 13859 entitled, "Boie-Takeda Chemicals Inc.
versus Department of Health, Hon. Alfredo R.A. Bengzon, et al.")
praying, among other reliefs, that a writ of preliminary injunction be
issued to restrain the Secretary of Health from enforcing BFAD
Regulation No. 1-A pending the determination of the case.
Upon receipt of the petition, the Court of Appeals issued a temporary
restraining order and set the hearing of the application for
preliminary injunction on February 22, 1988. After oral arguments at
the hearing, the parties submitted their respective memoranda.
On March 3, 1988, the Court of Appeals granted the writ prayed for
(Annex A, p. 98, Rollo).
This resolution of the Court of Appeals was elevated to Us by the
Secretary of Health on a petition for certiorari and prohibition with
preliminary injunction alleging grave abuse of discretion in issuing
the same.
As the issuance of a writ of preliminary injunction is an exercise of
the Court's sound discretion, the only point of inquiry in the
petition before Us is whether the Court of Appeals committed a grave
abuse of discretion in issuing the writ. The matter of whether the
respondent herein, Boie-Takeda (petitioner in the Appellate Court) was
denied due process of law in the proceedings before the administrative
bodies, namely, the Secretary of Health, the Bureau of Food and Drugs
(BFAD), the National Drug Committee (NDC), and the Technical Advisory
Committee on Registration of Products (TACORP), is not for Us to
determine as it is still pending adjudication in CA-G.R. SP No. 13859.
A writ of preliminary injunction, as an ancillary or preventive remedy
may only be resorted to by a litigant for the preservation or
protection of his rights or interests, and for no other purpose,
during the pendency of the principal action (Calo vs. Roldan, 76 Phil.
425).
Here, the writ was issued to protect and preserve the right or license
of the private respondent Boie-Takeda to market its product "Danzen"
in the Philippines, which it has been doing since 1970 or for the past
17 years. Hence the object of the writ is to preserve the status quo,
or the last actual peaceable uncontested status which preceded the
pending controversy (Rodulfa vs. Alfonso, 76 Phil. 225) which, as
correctly noted by the Court of Appeals, "is the status before the
withdrawal order" was issued. The status quo before the ban or
withdrawal order was issued, was that Boie-Takeda's product, "Danzen"
tablets, was registered and being sold in the Philippines under proper
license from the Bureau of Food and Drugs. That status quo is what the
writ of preliminary injunction seeks to preserve pending a final
determination of the merits of Boie-Takeda's petition in CA-G.R. SP
No. 13859.
Significantly, the writ was granted after a hearing where both parties
were given an opportunity to present their arguments which they
amplified with memoranda. (Said hearing SCRA 796). As a general rule,
this Court should refrain, in certiorari proceedings, from interfering
with the lower court's exercise of its discretion in issuing a writ of
preliminary injunction except in cases of manifest abuse (Rodulfa vs.
Alfonso, 76 Phil. 225; Agno River Gold Dredging Co. vs. De Leon, 61
Phil. 190; Detective & Protective Bureau, Inc. vs. Cloribel, 26 SCRA
255).
We rule, therefore, that respondent Court of Appeals did not commit a
grave abuse of discretion in issuing a writ of preliminary injunction
ordering the petitioners to desist from enforcing and implementing the
withdrawal order (BFAD Regulation No. 1-A dated April 10, 1988) at
least while the aggrieved party's petition for judicial review of the
administrative proceedings is still pending determination by that
Court.
WHEREFORE, the petition for certiorari and prohibition is denied.
SO ORDERED.
Narvasa, Cruz, Gancayco and Medialdea, JJ., concur.
The Lawphil Project - Arellano Law Foundation
I also found a very nice biography of the late Dr. Nieper:
http://www.findlongevitynow.com/aboutnieper_bio.html
Dr. Hans A. Nieper was born on May 23, 1928, in Hannover, Germany.
Both parents were physicians. His great-grandfather was the founder of
the mental hospitals in Ilten, near Hannover. His grandfather was a
well-known surgeon in Goslar. Dr. Nieper is active in Hannover as an
Internist and the Director of Medicine at the highly acclaimed
Paracelsus Silbersee Hospital. Patients seeking his assistance come
from all continents, predominantly North America, Europe, South Africa
and Australia. Internationally, he has become one of the best-known
physicians in the fields of cancerous diseases, multiple sclerosis,
mineral and electrolyte metabolism, aging, and the prevention of
cardiac disease.
Dr. Nieper studied in Mainz, Freiburg and Neuchâtel between 1946 and
1952. He completed his doctoral examinations "Summa Cum Laude," in
Hamburg, with the explanation of the so-called Boeck's sarcoid as an
autoimmune disease. At the time, such a disease principle was still
considered a utopian fabrication-today it is a recognised reality.
In the following decades, Dr. Nieper worked in various German medical
institutes and cancer research laboratories, instilling in him the
certainty that the cancer therapy practised then, and now (cancer
treatment with poisonous cytostatic substances) was predominantly on
the wrong track. As an internist, he engaged in scientific
investigation of important questions in the field of immunology, and
together with a very well-known German chemist, he discovered and
developed various new health curatives, which laid the foundation for
his later world-wide fame. These developments include the 'mineral
carriers' Aspartates and Orotates, as well as the salts of the cell
membrane component AEP, which can screen cell membranes from attack by
immune bodies. Dr. Nieper thus became the discoverer of the only
product officially declared, world-wide, as medication against
multiple sclerosis.
Towards the end of 1960, Dr. Nieper went to Aschaffenburg, to the
laboratory of the renowned cardiologist, Professor Kj. Blumberger,
where he began introducing potassium and magnesium aspartates into
heart therapy.
Because of his extensive study of non-poisonous methods for the
long-term treatment of cancer, he became a star witness for powerful
American civil rights organizations opposing toxic "orthodox" medicine
and government therapy regulation. For this reason, Dr. Nieper's
following in the English-speaking countries is counted in the
millions, and his influence in all fields is quite pronounced. He has
a close friendship with a large number of renowned scientists and
artists, including the American cancer researcher Dr. Dean Burk, the
best-known disciple of Berlin's double Novel-laureate Otto Warburg.
The routine introduction of selenium therapy for heart protection, the
introduction of the so-called deshielding or deblocking therapy of
cancer with pineapple enzymes and beta-carotene, and the modern
"de-sodification" of cancerous tumours represent only one phase of his
new clinical practical activities. Also the enzyme-based cleaning of
coronary and leg arteries is quite remarkable. In the year 1971, Dr.
Nieper, as a result of his own investigations, introduced
beta-carotene routinely into the protective cancer therapy. At the
time frequently ridiculed, this method is today fully accepted in the
scientific world literature as one of the most effective methods
available.
Around 1980, Dr. Nieper came to the scientific conclusion that the
potentially very effective defense against cancer by the body itself
has to be explained in terms of "gene repair," and not as an immune
defense alone. Soon after, anticancer gene repair substances were
found in man as well as in other species, such as in plants and
insects. This has proven to be a decisive turn in the fight against
cancer.
As early as 1946, Dr. Nieper became critical of certain aspects of the
predominant theories in physics. In 1953 he developed a so-called
shielding theory of gravitational effects, and reintroduced the ether
"abolished" by Einstein. In 1970, with the aid of American friends
such as the McNaughton Foundation of San Francisco, the founder of
AMPEX, A.M. Pontiatoff, and the Telluron Brain Center in Santa Monica,
he further developed his ideas on gravity. Because of his results, in
1973, he was presented to the U.S. Senate. There was further progress
in 1977, following a session at NASA-AMES at Moffett Field in
California, among well-known scientists, including Dr. Arthur D.
Alexander. There Dr. Nieper conceived of the so-called perisolar
cushion theory of the Tachyon-Field. (Complete explanation in Dr.
Nieper's Revolution in Technology Medicine and Society, the 384-page
book available in English, German and French advances today's
knowledge in several fields such as the conversion of Gravity Field
Energy and explains the inextricable relationship between the body's
cellular energy and our own personal health.)
Overall, Dr. Nieper has published approximately 360 articles and
essays and holds 131 International Patents.
Dr. Nieper is now the Honorary President of the German Association of
Vacuum Field Energy and Physics, after founding and presiding the
Association for 17 years. He also later co-founded the American
Association of Gravity Field Energy. These are the first associations
in the World dedicated to space energy technology.
In Germany, he is the founder and was the first 5-year President of
the German Society of Oncology. This biologically oriented cancer
society grows tremendously and is now the biggest cancer society in
all of Europe. He is also a life member of the German Society of
Natural Scientists and Physicians.
In the USA, Dr. Nieper is an active member of the New York Academy of
Sciences, the American Association for the Advancement of Sciences,
the American College of Nutrition and other societies. He was Honorary
President of the International Academy of Preventive Medicine for two
years and is also Honorary Director of this academy, along with double
Nobel-laureate Linus Pauling and vitamin chemist Roger Williams. He is
furthermore, an honorary member of the Center of Frontier Sciences,
Temple University, Philadelphia.
In Canada, he is a member of the Planetary Association for Clean
Energy.
In France, he is a member of the Société Agressologie, directed by his
friend, Henri Laborit.
Dr. Nieper died in his sleep on 21 October 1998. Although this is a
great loss to the global health community, he left behind a wealth of
information that will be beneficial for generations to come.
Here is a very interesting article about Serrapeptase:
http://www.clubnatural.com/serpowsilanc.html
The silkworm holds a treasure beyond the luxury of exquisite textiles.
It’s called serrapeptase (AKA Serratio Peptidase or SP, DanzenTM,
AniflazymTM SerraZymeTM), a powerful protolytic enzyme that dissolves
all nonliving tissue, including blood clots, cysts, arterial plaque
and inflammation in all forms.
The mighty enzyme offers a viable alternative to salicylates (such as
aspirin), ibuprofen, and NSAIDS as well as steroids—a boon for those
suffering with rheumatoid arthritis and a wide array of other
autoimmune diseases that affect the inflammatory response, including
ulcerative colitis, psoriasis, uveitis, allergies, and some forms of
cancer.
While steroidal and nonsteroidal antiinflammatory drugs may offer
temporary, symptomatic relief from pain, swelling and inflammation,
they may also be immunosuppressive and known to hold dangerous side
effects. Serrapeptase, on the other hand, eases pain and swelling with
no inhibitory effects on prostaglandins and no gastrointestinal side
effects. The immunologically active enzyme is completely bound to the
alpha 2 macroglobulin in biological fluids.
The physiologic agent is isolated from the microorganism Serratia E15,
an enzyme naturally present in the silkworm intestine which allows the
emerging moth to dissolve its cocoon. Clinical use of serrazyme as an
antiinflammatory in Europe and Asia spans over twenty five years.
Treatment includes chronic sinusitis, elimination of bronchopulmonary
secretions (the enzyme breaks down protein fibers, allowing mucous to
thin), sprains and torn ligaments, and other traumatic injuries,
idiopathic edema, as well as postoperative inflammation.
Studying postoperative swelling and pain reduction of the upper ankle
joint, a test was carried out in 3 randomized groups of 66 patients,
each with fresh rupture of the lateral ligament treated surgically
between December 1986 and April 1987. The group receiving SP saw a 50%
decrease in swelling on the third postoperative day. Decreased pain,
for the most part, correlated with reduction in swelling. The SP group
became rapidly pain-free. The two control groups, using traditional
elevation of the leg, bed rest, with and without applications of ice,
had no reduction in swelling at that time. (Esch PM, Gerngross H,
Fabian A, Fortachr Med,107(4):67.8, 71-2 1989 Feb 10)
Another multi-centre, double-blind, placebo-controlled trial was
carried out to investigate the clinical efficacy of SP in 174 patients
who underwent Caldwell-Luc antrotomy for chronic empyema. Eighty-eight
patients received 10 mg SP 3 times the day before surgery, once the
night of the operation and 3 times daily for 5 days after surgery; the
other 86 received a placebo. The degree of swelling in the
serrapeptase-treated patients was significantly less than that in the
placebo-treated patients at every point of observation after surgery
up to the 5th day. Maximal buccal swelling throughout all the
postoperative points of observation was also significantly smaller in
size in the SP group. No side effects were reported. (Tachibana M,
Mizukosi 0, Harada Y, Kawamoto K, Nakai Y. Source:
Pharmathera-peutica, 3(8):526-30 1984).
Additionally, SP in a 70 patient, double-blind controlled trial
treating breast engorgement saw SP improve breast pain and swelling in
significant numbers of the treatment group with no adverse reactions.
(Kee WH, Tan SL; Lee V, Salmon YM .Singapore Med J, 30(I) :48-54 1989
Feb)
Researchers in Germany have used SP to treat atherosclerosis since
serrapeptase helps to digest atherosclerotic plaque without harming
healthy cells lining the arterial wall. The hardened, narrow arterial
wall is considered the cumulative result of microscopic trauma with
inflammation occurring in the presence of oxidized lipids—serrapeptase
works on both inflammation as well as dissolving the avital plaque.
Unlike cholesterol-blocking drugs, serapeptase clears the avital
tissue from the arterial wall without interfering with cholesterol
synthesis. In fact, when taking serrapeptase, cholesterol levels may
rise as it is dissolved from the arteries to be eliminated from the
body (cholesterol in its pure state is an antioxidant and a necessary
component of steroidal hormones and the major organ systems in the
body).
Medications blocking cholesterol biosynthesis hold the threat of
liver, eye, lung and other soft tissue damage. While studies with SP
in the treatment of coronary artery disease are relatively new; some
literature reports SP as being superior to, and faster than,
chelation.
The late German physician Dr. Hans Nieper used serrapeptase to treat
arterial blockage in his coronary patients, reporting that
serrapeptase also dissolves blood clots, and causes varicose veins to
shrink or diminish. Dr. Nieper told of a woman scheduled for hand
amputation and a man scheduled for bypass surgery; both recovered
quickly without surgery after treatment with serrapeptase.
In addition, widespread use has included fibrocystic breast disease
and carpal tunnel syndrome.
The enzyme is also used to facilitate the therapeutic effect of
antibiotics in the treatment of infection. In urology serrapeptase has
been successfully employed to treat cystitis and epididymitis.
Serrapeptase is available as SerraZyme in 10 mg enterically coated
tablets that are equivalent to 20,000 IU activity.
Recommended Usage: For inflammation is 1 tablets three times daily on
an empty stomach. For arterial blockage 1 tablets twice daily or as
directed by your health professional. (In acute conditions, your
health care professional may recommend that you take 2 tablets on an
empty stomach 6 times per day). Copyright, Julia Busch 2000
Reprinted from the "So Young" holistic health, antiaging newsletter.
SerraZyme is available from the "So Young" catalog. To order (or for a
free antiaging catalog) call 800 SO YOUNG (800-769-6864) or email
julia2@gate.net
Obviously there are differing opinions concerning Serrapeptase. I
never listen to what others say and rely upon my own judgement.
Good luck, Redhoss |
